BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3782092 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08307
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8703W, LOT# J0056585R, IMPLANTED: 2001 (B)(6); PRODUCT TYPE CATHETER. (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON 2014 (B)(6), A POCKET FILL OCCURRED. THE PATIENT EXPERIENCED A BURNING SENSATION UPON INFUSION AND DEVELOPED HIVES AROUND THE PUMP. THE PATIENT BECAME LETHARGIC AND WAS SENT TO THE EMERGENCY ROOM (ER). THE PATIENT WAS LATER INTUBATED FOR APPROXIMATELY ONE DAY. AT THE TIME OF THIS REPORT, THE PATIENT HAD RECOVERED AND WAS DOING WELL. IT WAS NOTED THAT THE PUMP WAS VIEWED UNDER FLUOROSCOPY. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE AND CLONIDINE. IT WAS LATER REPORTED THAT THE CAUSE OF THE POCKET FILL WAS NOT DETERMINED. REGARDING THE RESULTS OF THE FLUOROSCOPY, THERE WERE NO KNOWN ISSUES WITH THE PUMP. THE PATIENT RECOVERED AND WAS RECEIVING THERAPY.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED OVERDOSE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260229 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Life Threatening| R